Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the pharmacokinetics and safety between single oral administration of br3006 and co-administration of br3006a, br3006b and br3006c in healthy adult volunteers under fasting conditions

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of br3006 and co-administration of br3006a, br3006b and br3006c in healthy adult volunteers under fasting conditions


Eligibility criteria:
inclusion criteria: * those who have body mass index (bmi) of 18.0kg/m2 to 30.0kg/m2 at screening visit. * for men, those who weigh 55 kg or more * for women, those who weigh 50 kg or more * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ethical drugs, over the counter drugs, herbal medicines, health functional foods concerned about affecting this clinical trial within 10 days before the first administration date. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have a medical history of gastrointestinal resection (except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs. * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months before the first administration date(however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * in the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.
oral health parameter-based diabetes type 2 indication using machine learning

Conditions: Type 2 Diabetes

Summary: this study aims to explore the potential of using machine learning (ml) algorithms to predict diabetes type2, based on oral health and demographic data. the objective is to evaluate the effectiveness of various ml models and identify the most relevant oral health indicators for predicting type 2 diabetes in individuals with mild cognitive impairment aged 60 and above.

this cross-sectional study utilizes oral health and demographic data from the swedish national study on aging and care (snac-b). participants aged 60 years or older with mild cognitive impairment will be included in the analysis. the data will be used to develop and evaluate machine learning models for predicting type 2 diabetes. objectives: 1. primary objective: to assess the potential of oral health parameters for binary classification of type 2 diabetes or not. 2. secondary objective: to identify the most influential oral health parameters contributing to type 2 diabetes predictions. 3. tertiary objective: to compare the performance of random forest (rf), support vector machine (svm), and catboost (cb) classifiers in predicting type 2 diabetes using oral health data.

Eligibility criteria:
inclusion criteria: * individuals aged 60 years or older. * participants with recorded oral health parameters with or without diabetes type2 exclusion criteria: • individuals with diabetes type1

Keywords: oral health machine learning diabetes type 2
kidney disease after covid-19

Conditions: COVID-19; Acute Kidney Injury; Chronic Kidney Injury

Summary: to understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in covid-19 survivors.


Eligibility criteria:
criteria: inclusion criteria: * adults, age ≥18 years * confirmed diagnosis of covid-19 exclusion criteria: • no confirmed diagnosis of covid-19
longitudinal natural history study of patients with peroxisome biogenesis disorders (pbd)

Conditions: Peroxisome Biogenesis Disorder; Zellweger Spectrum Disorder; RCDP - Rhizomelic Chondrodysplasia Punctata; D-Bifunctional Protein Deficiency; Alpha-Methylacyl-CoA Racemase Deficiency; Peroxisomal Acyl-CoA Oxidase Deficiency; Peroxisomal Acyl-CoA Oxidase 2 Deficiency; ATP Binding Cassette Subfamily D Member 3 Gene Mutation; ACBD5 (AcylCoA Binding Domain 5) Deficiency; Adult Refsum Disease; Sterol Carrier Protein 2 Deficiency

Summary: the peroxisome biogenesis disorders (pbd) are a group of inherited disorders due to defects in peroxisome assembly causing complex developmental and metabolic sequelae. in spite of advancements in peroxisome biology, the pathophysiology remains unknown, the spectrum of phenotypes poorly characterized and the natural history not yet systematically reported. our aims are to further define this population clinically, biochemically and genetically. the investigators will prospectively follow patients from canada, the us and internationally, and collect data from medical evaluations, blood, urine and imaging studies that would be performed on a clinical care basis. for patients who are unable to attend our clinic, we will collect all medical records and images since birth as well as subsequent records/images for the next 5 years or until the end of the study. clinical data from medical records will be banked in our peroxisomal disorder research databank and biobank. the investigators will use this information to identify standards of care and improve management.

participants have the option to be seen in consultation at the mcgill university health centre in montreal, canada, on a yearly basis. this includes a consultation in genetics, nutrition, neurology, and ophthalmology (oct and faf exams). all medical records and images will be collected, retrospectively and prospectively, until the end of the study, and entered anonymously in a database. biospecimens will be collected to identify new biomarkers. candidate drugs will be evaluated for recovery of peroxisome functions in cultured fibroblasts.

Eligibility criteria:
inclusion criteria: * diagnosis of pbd or * single peroxisome enzyme/protein defect with phenotype similar to pbd exclusion criteria: * not a pbd * not a single peroxisome enzyme/protein defect with phenotype similar to pbd

Keywords: peroxisome biogenesis disorders pbd zellweger spectrum disorder rhizomelic chondrodysplasia punctata dbp acox1 amacr ard acbd5 zsd rcdp acox2 abcd3 adult refsum phyh scpx rcdp1 rcdp2 rcdp3
frailty in people living with hiv aged 70 years or more

Conditions: HIV Infections

Summary: the anrs ep66 septavih study aims to screen feasibility of evaluating frailty in people living with hiv aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events. septavih is a french, multicentre, prospective, observational study which will include 500 hiv-infected participants

the primary objective is to assess the prevalence of frailty at baseline in people living with hiv (plwh) aged 70 years and older, using the fried index. the main secondary objectives of this study are : * to assess frequency frailty according to different indexes or scores (fried, health deficits index, has score, vacs index) * to evaluate the association between frailty and specific hiv-related characteristics (for example known duration of hiv infection), or non-specific factors (such as non- hiv-related diseases or living conditions) * to evaluate theproportion of subjects with a pejorative event at 60 months of follow-up (recurrent or serious falls, emergency department visit, unscheduled hospitalization, institutionalization, loss of one point on the iadl scale or death) * to evaluate the association between baseline frailty status and early / long-term pejorative events incidence * association between baseline evaluation of frailty and pejorative events incidence during the 60 months of follow-up. * transition between frail or non frail status during the 60 months of follow-up * to assess the prevalence of sarcopenia and osteoporosis * to describe study population including : * demographic characteristics * hiv medical history and antiretroviral therapy * comorbidities, polymedication and evaluation of drug-drug interactions * mental health, quality of life, socioeconomic status * healthcare use and additional care implementation (nursing, physical therapy, home care services, ...) * assessment of inflammatory and immunosenescence biomarkers at baseline * anthropologic substudy about hiv and polypathologies management * focus on covid-19 with clinical questionnaire, self-administrated questionnaire, sars cov2 serology and biobank (serum library)

Eligibility criteria:
inclusion criteria: * patient aged 70 years and older * hiv-1 infection * antiretroviral therapy for at least 12 months * free and signed informed consent (article l1122-1-1-1 of the french public health code) * person affiliated or benefiting from a social security scheme - exclusion criteria: * participation in another research study excluding participation in other studies * person under legal protection or deprived of liberty by a judicial or administrative decision * isolated hiv-2 infection * life expectancy of less than 6 months
effects of cryotherapy on joint function and pressure pain threshold in patients with subacromial impingement syndrome.

Conditions: Pain; Inflammation

Summary: background: subacromial impingement syndrome (sis) is a chronic and disabling disease, characterized by compression and mechanical abrasion of the tendons of the rotator cuff muscles, subacromial bursa and tendon of the long head of the biceps against the anterior surface of the acromion, coracoacromial ligament or the acromioclavicular joint during arm elevation movement. after the trauma, inflammatory processes initiate and may lead to loss of function when untreated. this inflammation leads the release of cytokines (il-6, il-10, il-1β and tnf-α) whose acts as inflammatory mediators. physical therapy works in treating sis with the goal of reducing pain and inflammatory process. cryotherapy is widely used in physical therapy by anti-inflammatory and analgesic effects, low cost, effectiveness and easy application. objective: the aim of the study is to evaluate the effects of a cryotherapy protocol, applied on shoulder of subjects with sis, on serum inflammatory mediators (cytokines) and local pressure pain threshold. possible changes in function and pain will also be evaluated. materials and methods: 30 subjects will be selected and share in two groups, 15 healthy subjects and 15 subjects with sis. function assessments and quality of life will be held using the dash and worc questionnaires. cryotherapy will be applied for 4 consecutive days, lasting 20 minutes without interruption through ice pack over the shoulder of sis carriers. for the blood samples, 20ml of blood will be collected at the first and last day of the intervention, and then stored at -80 ° c.


Eligibility criteria:
definition: the participants will be selected from population in general and will be screened by the inclusion and exclusion criteria below: inclusion criteria: * the diagnosis for sis will be based on a clinical examination and self-reported orthopaedic history. at least 3 positive tests of: neer impingement test, hawkins impingement test, jobe test, speed test or gerber test, pain with passive or isometric resisted shoulder lateral rotation, pain with active shoulder elevation and pain with palpation of rotator cuff tendons. exclusion criteria: * fracture, osteoporosis, malignancy, infection, and active inflammatory process, pregnancy, systemic illnesses, physical therapy or manual therapy treatment within 6 months prior to the evaluation, signs of complete rotator cuff tear or acute inflammation, cervicothoracic spine-related symptoms (positive cervical compression test and excessive kyphosis), scoliosis, glenohumeral instability (positive apprehension, anterior drawer, or sulcus tests), or previous upper extremity fracture or shoulder surgery.

Keywords: subacromial impingement physical therapy cryotherapy
is gender a factor in patients with subacromial shoulder pain?

Conditions: Subacromial Pain Syndrome

Summary: this study aimed to investigate the effects of gender on pain, functionality, range of motion, disability level and position sense parameters in patients with subacromial shoulder pain.


Eligibility criteria:
inclusion criteria: 1. being between the ages of 18-65 2. being diagnosed with unilateral subacromial impingement syndrome 3. not having received steroid injections or physical therapy for shoulder problems in the last 6 months 4. having painful shoulder pain for the last 3 months 5. being willing to participate in the study exclusion criteria: 1. having a rheumatic, neurological, cardiovascular, psychiatric or systemic disorder 2. having a surgical operation on the shoulder, cervical and thoracic region 3. having a neurological deficit, fracture or history of fracture in the upper extremity 4. having cervical radiculopathy 5. having communication problems

Keywords: subacromial shoulder pain functionality disability position sense
open-label extension study to evaluate the safety of usl255 in patients with refractory partial-onset seizures

Conditions: Epilepsy

Summary: the purpose of this study is to examine the safety of usl255 as adjunctive therapy in patients with refractory partial onset-seizures.


Eligibility criteria:
inclusion criteria: * have completed the maintenance period of the p09-004 study. * continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant aeds.

Keywords: epilepsy partial onset seizure adjunctive therapy
effect of aureobasidium pullulans produced β-glucan on musculoskeletal biomarkers in adults with relative sarcopenia

Conditions: Sarcopenia

Summary: the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.

a previous study has indicated that aureobasidium pullulans produced β-glucan may increase muscle mass and strength. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of aureobasidium pullulans produced β-glucan on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia; the safety of the compound are also evaluated. the investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. eighty adults were administered either 1,000 mg of aureobasidium pullulans produced β-glucan or a placebo each day for 12 weeks.

Eligibility criteria:
inclusion criteria: * \<110% of the standard lean body mass as measured using the body composition analyzer * body mass index (bmi) ranging from 18.5 to 30.0 kg/m2 * those who have an average protein intake of 60 g or more/day. exclusion criteria: * abnormal liver or renal function (more than twice the normal upper limit of the research institute) * uncontrolled diabetes mellitus (\>160 mg/dl of fasting blood sugar) * history of fracture during the previous year * uncontrolled hypertension (\>160/100 mmhg) * uncontrolled thyroid diseases. * history of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months * history of any central bone fracture within 1 year * history of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication. * alcohol abuser * allergic reaction to aureobasidium pullulans produced β-glucan * those who participated in other drug clinical trials within 1 month from the screening date. * severe gastrointestinal symptoms such as heartburn and indigestion * those who are pregnant, lactating, or plan to become pregnant during the clinical trial * those who are judged to be unsuitable by the pi for other reasons
ketoprofen topical patch, 20% in the treatment of pain associated with osteoarthritis flare of the knee

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with osteoarthritis flare of the knee.

this randomized, double-blind placebo-controlled parallel group study will be conducted with patients who have experienced a flare of osteoarthritis of the knee. at screening, patients whose pain is currently controlled by an analgesic will agree, after giving informed consent, to discontinue that analgesic. eligible patients will be randomized (1:1 ratio) to receive double-blind treatment with either the ketoprofen topical patch or a matching placebo patch to be applied once daily for 28 days. patients will return to the clinic on days 7, 14, 21 and 28. at day 28, patients may choose to open a 2 month open-label period. patients will rate their pain using the knee injury and osteoarthritis outcome score (koos) which contains the womac pain subscale. patients will also complete an electronic diary in which pain intensity, pain relief, and quality of sleep ratings will be captured. in addition, rescue medication consumption data will be collected. ibuprofen will be provided as prn rescue medication.

Eligibility criteria:
inclusion criteria: * males or females 18 years of age or older * diagnosis of osteoarthritis of the knee (unilateral or bilateral) * meet pain entry criteria * willing to discontinue use of all analgesic medications (including over-the-counter \[otc\] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes. exclusion criteria: * positive urine pregnancy test, pregnant or lactating. * have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or paget's disease * have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee * have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit * have a history or physical examination finding that is incompatible with safe participation in the study or study product use * are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions. * have significant renal or hepatic impairment * are taking a sleep medication at a dose that has not been stable for at least 3 months

Keywords: pain osteoarthritis knee nsaid
visual spatial exploration and art therapy intervention in patients diagnosed with parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this dual phase cross-sectional, controlled and prospective, open label, exploratory study is to determine the general characteristics of visuospatial exploration and its neural substrate in subjects with parkinson's disease (pd) and to explore the impact of professional art therapy intervention in a cohort of subjects with parkinson's disease on visuospatial exploration, visuomotor integration, neuropsychological and emotional sphere, quality of daily living and motor symptoms.


Eligibility criteria:
inclusion criteria: inclusion criteria (patients with pd) * diagnosis of pd according to united kingdom parkinson's disease society brain bank; * hoehn and yahr stage 2 to 3; exclusion criteria: exclusion clinical criteria (for both pd and controls): * history of dementia, or moca \< 22; * untreated depression, or score of \>20 on beck depression inventory ii; * history of florid visual, tactile, olfactory or acoustic hallucinations requiring the administration of neuroleptics. * presence of psychosis requiring the administration of neuroleptics or sedatives. * presence of severe motor fluctuations with most of the 50% of day spent in off-time. * presence of bothersome dyskinesias. * presence of severe dystonia involving the head-neck axis including anterocollis, laterocollis and torticollis. * presence of severe fluctuations in attention, alertness or cognition. * presence of any clinically significant abnormality on vital signs. exclusion ophthalmologic and ophtalmometric criteria (for both pd and controls): * visual abnormalities requiring exclusive correction with eye glasses (of note, contact lenses are not an exclusion criterion). * history of clinically active ophthalmologic abnormalities including but not limited to macular degeneration, symptomatic cataract, symptomatic retinopathy, recent orbital trauma with periorbital ecchymosis, symptomatic thyroid eye disease, refractory problems of moderate or severe degree (of note, mild refractory problems are not an exclusion criterion, chromatic discrimination problems including daltonism are not an exclusion criterion). * history of any clinically significant cns abnormality resulting in an active visual field deficit including but not limited to brain tumors, brain abscess, inflammatory encephalic lesions, traumatic brain injury or stroke. * clinically significant abnormal findings on routine bedside examination of the vision system during a standard clinical neurological exam. exclusion mri criteria (for both pd and controls): * major or unstable medical illness; * left hand dominance; * pacemakers, neurostimulators, intracranial clips, metal implants, external clips or metal foreign bodies within 10 cm of the head; * current pregnancy or nursing; * pregnancy planned; * claustrophobia; * large body habitus (280 lb or more) exclusion criteria for art therapy (for pd subjects only): * severe inability to perform line drawing; * severe inability to manipulate soft/light materials like clay.

Keywords: art therapy
postural assessment in plagiocephaly

Conditions: Plagiocephaly

Summary: the positional plagiocephaly is a condition involving craniofacial asymmetry. the purpose of this study is to evaluate the spine, the posture and the psychomotor state in children who were diagnosed with infant plagiocephaly.

positional infant plagiocephaly is a clinical entity in which the shape of an infant's head becomes altered as the result of external forces applied to the malleable bones of the cranium and can occur pre- or postnatally. it is characterized by asymmetric occipital flattening (one side or the central part of the occiput is flattened)with ipsilateral frontal bossing.viewed from above, this results in a parallelogram deformity of the head. we hypothesize that children who had plagiocephaly when they were infants, they have postural and spine implications at 3-5 years old.

Eligibility criteria:
inclusion criteria: * diagnosis of infant positional plagiocephaly * aged 3, 4 or 5 years old. exclusion criteria: * diagnosis of non synostotic plagiocephaly. * neurological concomitant condition. * problems in motor development.

Keywords: plagiocephaly posture spine